Records for Alcohol Care Enhancement

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05492942

Acronym

RACE

Enrollment

134

Registered

2022-08-09

Start date

2022-11-11

Completion date

2024-11-28

Last updated

2025-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use Disorder (AUD)

Keywords

Unhealthy alcohol use, Best Practice Advisory (BPA), Clinical care management (CCM), Population health management (PHM), Substance use disorder (SUD)

Brief summary

Unhealthy alcohol use (the spectrum from risky consumption through alcohol use disorder, AUD) is a leading cause of preventable death in the US (88,424 deaths annually costing $249 billion a year), and alcohol-related health harms (e.g. AUD itself, cirrhosis) are increasing. Despite high frequency of contacts with the medical system, most people with unhealthy alcohol use do not receive evidence-based interventions due to factors such as stigma, lack of knowledge, challenges with implementing and maintaining tool-based screening, time or prioritization constraints, and more. Electronic health records (EHRs), Best Practice Advisories (BPA) and registries are known and practical tools to improve management and care of chronic disease by aggregating information about the target population, and by assisting the clinician in reminders, decision support, and disease-specific care management. EHRs may help clinicians identify, assess, treat and monitor care when assisted by targeted staff support such as a clinical care manager (CCM) and population health manager (PHM). These support staff help to track outcomes of care and treatments, allowing for increased engagement with the population, and facilitation of care.

Detailed description

The study team created a live database/registry of patients with unhealthy alcohol use in the Boston Medical Center (BMC) electronic health record (Epic), and updated Epic-based best practice advisories (BPA) and clinical decision support (CDS) (Epic Smart Set) for risky alcohol use and AUD. To improve recognition, management, and overall services provided to patients with AUD, this trial aims to test the impact of these EHR tools (the BPA, CDS, registry and registry-based reporting) for risky alcohol use and AUD by incorporating a population health manager (PHM) and clinical care manager (CCM) to augment reach and support to clinicians, and test the feasibility and effectiveness of leveraging EHRs and targeted supports to improve AUD care. A four-group randomized control trial will be implemented to determine which of four interventions is most effective at increasing rates of initiation and engagement in AUD treatment, as well as other clinical processes and outcomes. The trial will compare the use of the 1) BPA alone (only Epic-based clinician prompting and CDS), 2) BPA + PHM, 3) BPA + CCM, and 4) BPA + PHM + CCM, on the trials' primary, secondary, and exploratory outcomes. Trial results will be assessed by examining outcomes for patients on the clinician's panel.

Interventions

BEHAVIORALBest Practice Advisory (BPA) and Population Health Management (PHM)

A clinician will have continued access to the existing Epic BPA that provides clinical decision support and management for risky alcohol use and alcohol use disorder (AUD). Additionally, a clinician will be supported by a PHM who can access and existing registry of patients with possible or confirmed AUD to examine quality metrics for patients with an AUD on the provider panel. The PHM will circulate quarterly reports to the clinicians in this group to provide performance metric data that indicates the proportion of patients on their primary care panel who are initiating and engaging in AUD treatment. Additionally, the PHM will circulate a weekly report of higher risk patients on the clinician's panel who recently had an acute care visit for AUD and could benefit from outreach for follow-up care. PHM does not directly help clinicians with implementation of care with individual patients, and has no direct patient contact.

BEHAVIORALBest Practice Advisory (BPA) and Clinical Care Management (CCM)

A clinician will have continued access to the existing Epic BPA that provides clinical decision support and management for risky alcohol use and alcohol use disorder (AUD). The clinician will be supported by a CCM who will assist in identifying patients who need further assessment on the clinician patient panel. The CCM will conduct outreach to patients regarding alcohol use care, and will communicate with the clinician to help decide potential care plans, and then assist in implementing those plans for patients. The CCM has expertise on how to provide appropriate care to patients and can help patients navigate the complex care system. Further assistance by the CCM may include facilitating prescriptions for clinician sign-off, assuring refills, finding, selecting and coordinating specialty AUD care, and contacting patients to make appointments.

BEHAVIORALBest Practice Advisory (BPA) and Population Health Management (PHM) and Clinical Care Management (CCM)

A clinician will have continued access to the existing Epic BPA that provides clinical decision support and management for risky alcohol use and alcohol use disorder (AUD). Additionally, a clinician will be supported by a PHM and clinical care manager CCM. The PHM can access and existing registry of patients with possible or confirmed alcohol use disorder to examine quality metrics for patients with an alcohol use disorder on the provider panel. The PHM will circulate quarterly reports to the clinicians in this group to provide summaries of data of those who have initiated or engaged in treatment for alcohol use, as well as a weekly report of higher risk patients on their panel who recently had an acute care visit for AUD and could benefit from outreach for follow-up care. The CCM will assist in identifying patients who need further assessment, and will assist in conducting outreach and implementing care to those patients regarding alcohol use care.

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

for Clinician Participants: * Adult (18 years or older) * Physician or Nurse Practitioner * Practices Primary Care at Boston Medical Center in the General Internal Medicine (GIM) Primary Care Clinic * Current position in the practice expected to be unchanged for a minimum of 18 months (not a graduating trainee) Inclusion Criteria for Patient Participants: Records (EHR, Medicaid accountable care organizations (ACO) claims) from all patients empaneled (patient is assigned to PCP's primary care panel) by study enrolled clinicians who are: * Adult (18 years or older) * Have had at least 1 completed visit in general internal medicine at BMC during the last 18 months.

Exclusion criteria

• Clinicians who, at the time of study recruitment, are expected to remain in their BMC GIM position for less than 18 months (e.g. resident or fellow trainees expected to graduate within the study time period).

Design outcomes

Primary

Measure	Time frame	Description
Percent of New Alcohol Use Disorder (AUD) Diagnosis Episodes That Meet Criteria for AUD Treatment Engagement Among Patients With a New AUD Diagnosis Who Are Empaneled to Randomized Clinicians.	The outcome measure is assessed within 48 days following the date of the new AUD diagnosis, among patients empaneled to randomized clinicians.	The percent of new AUD diagnosis episodes that meet criteria for AUD treatment engagement among patients with a new AUD diagnosis on a randomized clinician's panel. Engagement is defined as having two or more healthcare services (inclusive of AUD medication) with a diagnosis of AUD within 34 days of meeting initiation, which is defined as having a healthcare service for AUD within 14 days of a new AUD diagnosis. A new AUD diagnosis is defined as a health service in which a patient receives a new AUD diagnosis when there has not been an AUD diagnosis during the prior 194 days, excluding diagnoses assigned in emergency department/detox. Outcome is reported at the empaneled patient level. Outcome measure time frame is based on definitions of initiation and engagement. Engagement is assessed within 34 days following treatment initiation, and initiation is assessed within 14 days of a new AUD diagnosis (34 days + 14 days =a maximum possible outcome measure time frame of 48 days).

Secondary

Measure	Time frame	Description
Percent of New Alcohol Use Disorder (AUD) Diagnosis Episodes That Meet Criteria for AUD Treatment Initiation Among Patients With a New AUD Diagnosis Who Are Empaneled to Randomized Clinicians	The outcome measure is assessed within 14 days following the date of the new AUD diagnosis, among patients empaneled to randomized clinicians.	The percent of new AUD diagnosis episodes that meet criteria for AUD treatment initiation among patients with a new AUD diagnosis on a randomized clinician's panel. Initiation is defined as having a healthcare service for AUD within 14 days of a new AUD diagnosis. A new AUD diagnosis is defined as a health service in which a patient receives a new AUD diagnosis when there has not been an AUD diagnosis during the prior 194 days, excluding diagnoses assigned in the emergency department/detox. Outcome is reported at the empaneled patient level. Outcome measure time frame is based on definitions of initiation. Initiation is assessed within 14 days of a new AUD diagnosis (14 days is the maximum possible outcome measure time frame). Outcome is assessed in Medicaid claims.
Percent of New Alcohol Use Disorder (AUD) Diagnosis Episodes Within Which an AUD Medication is Prescribed Within 90 Days of the New AUD Diagnosis Among Patients Who Are Empaneled to Randomized Clinicians	Outcome measure is assessed 90 days following the date of the new AUD diagnosis, among patients empaneled to randomized clinicians.	Percent of new Alcohol Use Disorder (AUD) diagnosis episodes within which an AUD medication is prescribed within 90 days of the new AUD diagnosis among patients who are empaneled to randomized clinicians AUD medications include: Naltrexone, Intramuscular (IM) Naltrexone, Acamprosate, or Disulfiram. Outcome is reported at the new AUD diagnosis episode level among patients empaneled to randomized clinicians. Outcome measure time frame is assessed within 90 days of a new AUD diagnosis.
Number of Boston Medical Center (BMC) Outpatient Encounters With an AUD Billing Diagnosis Within 90 Days of a New AUD Diagnosis, Among Patients Who Are Empaneled to a Randomized Clinician.	The outcome measure is assessed within 90 days following the date of the new AUD diagnosis, among patients empaneled to randomized clinicians.	Number of Boston Medical Center (BMC) outpatient encounters with an AUD billing diagnosis within 90 days of a new AUD diagnosis, among patients with a new AUD diagnosis who are empaneled to a randomized clinician. Outcome is reported at the new AUD diagnosis episode level. Outcome measure time frame is assessed within 90 days of a new AUD diagnosis.
Number of BMC Mental Health Clinician Encounters With an AUD Billing Diagnosis Within 90 Days of a New AUD Diagnosis, Among Patients Who Are Empaneled to a Randomized Clinician.	The outcome measure is assessed within 90 days following the date of the new AUD diagnosis, among patients empaneled to randomized clinicians.	Number of BMC mental health clinician encounters with an AUD billing diagnosis within 90 days of a new AUD diagnosis, among patients with a new AUD diagnosis who are empaneled to a randomized clinician. Outcome is reported at the empaneled patient level. Outcome measure time frame is assessed within 90 days of a new AUD diagnosis.
Number of BMC AUD Specialty Care Encounters With an AUD Billing Diagnosis Within 90 Days of a New AUD Diagnosis, Among Patients Who Are Empaneled to a Randomized Clinician.	The outcome measure is assessed within 90 days following the date of the new AUD diagnosis, among patients empaneled to randomized clinicians.	Number of BMC AUD specialty care encounters with an AUD billing diagnosis within 90 days of a new AUD diagnosis, among patients with a new AUD diagnosis who are empaneled to a randomized clinician. Outcome is reported at the empaneled patient level. Outcome measure time frame is assessed within 90 days of a new AUD diagnosis.
Number of Acute Care Encounters Among Patients With a New AUD Diagnosis Who Are Empaneled to Randomized Clinicians.	The outcome measure is assessed within 90 days following the date of the new AUD diagnosis, among patients empaneled to randomized clinicians.	Number of acute care encounters (emergency department visits and hospitalizations) within 90 days of a new AUD diagnosis, among patients with a new AUD diagnosis who are empaneled to a randomized clinician. Outcome is reported at the empaneled patient level. Outcome measure time frame is assessed within 90 days of a new AUD diagnosis. Outcome is assessed in Medicaid claims.
Number of Acute Care Utilization Encounters With an Alcohol-related Diagnosis Among Patients With a New AUD Diagnosis Who Are Empaneled to Randomized Clinicians	The outcome measure is assessed within 90 days following the date of the new AUD diagnosis, among patients empaneled to randomized clinicians.	Number of acute care utilization encounters (emergency department visits and hospitalizations), with an alcohol-related diagnosis within 90 days of a new AUD diagnosis, among patients with a new AUD diagnosis on are empaneled to a randomized clinician. Outcome is reported at the empaneled patient level. Outcome measure time frame is assessed within 90 days of a new AUD diagnosis. Outcome is assessed in Medicaid claims.
Number of Referrals for Counseling or Specialty AUD Care Within 90 Days of a New AUD Diagnosis, Among Patients Who Are Empaneled to a Randomized Clinician.	The outcome measure is assessed within 90 days following the date of the new AUD diagnosis, among patients empaneled to randomized clinicians.	Number of referrals for counseling or specialty AUD care such as the BMC Office Based Addiction Treatment (OBAT), Center for Addiction Treatment for AdoLescent/Young adults who use SubsTances (CATALYST), etc., within 90 days of a new AUD diagnosis, among patients with a new AUD diagnosis who are empaneled to a randomized clinician. Outcome is reported at the empaneled patient level. Outcome measure time frame is assessed within 90 days of a new AUD diagnosis.

Countries

United States

Participant flow

Recruitment details

Only clinicians were consented and enrolled. Randomization and the intervention occurred at the clinician level. Outcomes were observed among primary care patients of randomized clinicians.

Participants by arm

Arm	Count
Clinician Prompting and Decision Support, Best Practice Advisory (BPA) Access to an existing BPA for risky alcohol use and alcohol use disorder.	30
BPA Plus Population Health Management (BPA+PHM) Access to the existing Epic BPA for risky alcohol use and alcohol use disorder + targeted support by a population health manager (PHM). Best Practice Advisory (BPA) and Population Health Management (PHM): A clinician will have continued access to the existing Epic BPA that provides clinical decision support and management for risky alcohol use and alcohol use disorder (AUD). Additionally, a clinician will be supported by a PHM who can access and existing registry of patients with possible or confirmed AUD to examine quality metrics for patients with an AUD on the provider panel. The PHM will circulate quarterly reports to the clinicians in this group to provide performance metric data that indicates the proportion of patients on their primary care panel who are initiating and engaging in AUD treatment. Additionally, the PHM will circulate a weekly report of higher risk patients on the clinician's panel who recently had an acute care visit for AUD and could benefit from outreach for follow-up care. PHM does not directly help clinicians with implementation of care with individual patients, and has no direct patient contact.	36
BPA Plus Clinical Care Management (BPA+CCM) Access to the existing Epic BPA for risky alcohol use and alcohol use disorder + targeted support by a clinician care manager (CCM). Best Practice Advisory (BPA) and Clinical Care Management (CCM): A clinician will have continued access to the existing Epic BPA that provides clinical decision support and management for risky alcohol use and alcohol use disorder (AUD). The clinician will be supported by a CCM who will assist in identifying patients who need further assessment on the clinician patient panel. The CCM will conduct outreach to patients regarding alcohol use care, and will communicate with the clinician to help decide potential care plans, and then assist in implementing those plans for patients. The CCM has expertise on how to provide appropriate care to patients and can help patients navigate the complex care system. Further assistance by the CCM may include facilitating prescriptions for clinician sign-off, assuring refills, finding, selecting and coordinating specialty AUD care, and contacting patients to make appointments.	34
BPA Plus Population Health Management Plus Clinical Care Management (BPA+PHM+CCM) Access to the existing Epic BPA risky alcohol use and alcohol use disorder + targeted support by a population health manager (PHM) and clinician care manager (CCM) Best Practice Advisory (BPA) and Population Health Management (PHM) and Clinical Care Management (CCM): A clinician will have continued access to the existing Epic BPA that provides clinical decision support and management for risky alcohol use and alcohol use disorder (AUD). Additionally, a clinician will be supported by a PHM and clinical care manager CCM. The PHM can access and existing registry of patients with possible or confirmed alcohol use disorder to examine quality metrics for patients with an alcohol use disorder on the provider panel. The PHM will circulate quarterly reports to the clinicians in this group to provide summaries of data of those who have initiated or engaged in treatment for alcohol use, as well as a weekly report of higher risk patients on their panel who recently had an acute care visit for AUD and could benefit from outreach for follow-up care. The CCM will assist in identifying patients who need further assessment, and will assist in conducting outreach and implementing care to those patients regarding alcohol use care.	34
Total	134

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Overall Study	The clinician did not have an active patient panel eligible for outcome for the full 18 months	10	7	8	13

Baseline characteristics

Characteristic	Clinician Prompting and Decision Support, Best Practice Advisory (BPA)	Total	BPA Plus Population Health Management Plus Clinical Care Management (BPA+PHM+CCM)	BPA Plus Clinical Care Management (BPA+CCM)	BPA Plus Population Health Management (BPA+PHM)
Age, Continuous	36 years STANDARD_DEVIATION 12	37 years STANDARD_DEVIATION 12	37 years STANDARD_DEVIATION 13	38 years STANDARD_DEVIATION 14	34 years STANDARD_DEVIATION 11
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants	13 Participants	5 Participants	1 Participants	4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants	117 Participants	29 Participants	33 Participants	28 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	4 Participants	0 Participants	0 Participants	4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	9 Participants	37 Participants	6 Participants	10 Participants	12 Participants
Race (NIH/OMB) Black or African American	4 Participants	9 Participants	3 Participants	1 Participants	1 Participants
Race (NIH/OMB) More than one race	1 Participants	3 Participants	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	11 Participants	3 Participants	0 Participants	7 Participants
Race (NIH/OMB) White	15 Participants	74 Participants	21 Participants	23 Participants	15 Participants
Sex/Gender, Customized Female	17 Participants	77 Participants	16 Participants	27 Participants	17 Participants
Sex/Gender, Customized Male	13 Participants	53 Participants	18 Participants	7 Participants	15 Participants
Sex/Gender, Customized Nonbinary or Missing	0 Participants	4 Participants	0 Participants	0 Participants	4 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	0 / 30	0 / 36	0 / 34	0 / 34
other Total, other adverse events	0 / 30	0 / 36	0 / 34	0 / 34
serious Total, serious adverse events	0 / 30	0 / 36	0 / 34	0 / 34

Outcome results

Primary

Percent of New Alcohol Use Disorder (AUD) Diagnosis Episodes That Meet Criteria for AUD Treatment Engagement Among Patients With a New AUD Diagnosis Who Are Empaneled to Randomized Clinicians.

The percent of new AUD diagnosis episodes that meet criteria for AUD treatment engagement among patients with a new AUD diagnosis on a randomized clinician's panel. Engagement is defined as having two or more healthcare services (inclusive of AUD medication) with a diagnosis of AUD within 34 days of meeting initiation, which is defined as having a healthcare service for AUD within 14 days of a new AUD diagnosis. A new AUD diagnosis is defined as a health service in which a patient receives a new AUD diagnosis when there has not been an AUD diagnosis during the prior 194 days, excluding diagnoses assigned in emergency department/detox. Outcome is reported at the empaneled patient level. Outcome measure time frame is based on definitions of initiation and engagement. Engagement is assessed within 34 days following treatment initiation, and initiation is assessed within 14 days of a new AUD diagnosis (34 days + 14 days =a maximum possible outcome measure time frame of 48 days).

Time frame: The outcome measure is assessed within 48 days following the date of the new AUD diagnosis, among patients empaneled to randomized clinicians.

Population: The overall number of participants analyzed is randomized clinicians in the study. We have listed the number of randomized clinicians in each study arm. The unit of analysis is new alcohol use disorder diagnoses among patients empaneled to randomized clinicians in each study arm. Data source: Medicaid Claims Data

Arm	Measure	Value (COUNT_OF_UNITS)
Clinician Prompting and Decision Support, Best Practice Advisory (BPA)	Percent of New Alcohol Use Disorder (AUD) Diagnosis Episodes That Meet Criteria for AUD Treatment Engagement Among Patients With a New AUD Diagnosis Who Are Empaneled to Randomized Clinicians.	10 New AUD diagnosis episodes
BPA Plus Population Health Management (BPA+PHM)	Percent of New Alcohol Use Disorder (AUD) Diagnosis Episodes That Meet Criteria for AUD Treatment Engagement Among Patients With a New AUD Diagnosis Who Are Empaneled to Randomized Clinicians.	11 New AUD diagnosis episodes
BPA Plus Clinical Care Management (BPA+CCM)	Percent of New Alcohol Use Disorder (AUD) Diagnosis Episodes That Meet Criteria for AUD Treatment Engagement Among Patients With a New AUD Diagnosis Who Are Empaneled to Randomized Clinicians.	12 New AUD diagnosis episodes
BPA Plus Population Health Management Plus Clinical Care Management (BPA+PHM+CCM)	Percent of New Alcohol Use Disorder (AUD) Diagnosis Episodes That Meet Criteria for AUD Treatment Engagement Among Patients With a New AUD Diagnosis Who Are Empaneled to Randomized Clinicians.	30 New AUD diagnosis episodes

Secondary

Number of Acute Care Encounters Among Patients With a New AUD Diagnosis Who Are Empaneled to Randomized Clinicians.

Number of acute care encounters (emergency department visits and hospitalizations) within 90 days of a new AUD diagnosis, among patients with a new AUD diagnosis who are empaneled to a randomized clinician. Outcome is reported at the empaneled patient level. Outcome measure time frame is assessed within 90 days of a new AUD diagnosis. Outcome is assessed in Medicaid claims.